BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    MDR report key: 3801168 · Received May 8, 2014

    Report

    Report Number
    2015691-2014-01075
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    September 2, 2010
    Report Date
    April 11, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. WITHOUT RETURN OF THE DEVICE, EDWARDS IS UNABLE TO CONFIRM THE CLINICAL OBSERVATION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    EDWARDS HAS RECEIVED INFORMATION THAT THIS BIOPROSTHETIC MITRAL VALVE HAS EXHIBITED MODERATE REGURGITATION AFTER AN IMPLANT DURATION OF ONE (1) MONTH. SUBSEQUENTLY, AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND SEVEN (7) MONTHS, THIS HAS INCREASED TO SEVERE REGURGITATION WITH A GRADIENT OF 17 MMHG (MEAN) AND 39 MMHG (PEAK). THE DEVICE REMAINS IMPLANTED AND THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATED POST-OPERATIVE ECHO REVEALED THICKENED MITRAL LEAFLETS WITH RESTRICTED MOTION AND SEVERE MITRAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278941 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7000TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR